摘要
About the Role
~ 管理多个大型和复杂的全球监管提交项目。
~ 制定和提供提交材料，为开发、注册和维护全球产品所需的技术相关监管战略、情报和知识做出贡献。
~ 促进战略和技术投入/支持，推动全球系统、工具和流程的实施，以支持全球发展项目和/或营销产品。
~ 经验丰富的专业人才，对专业领域有充分的了解：以创造性的方式解决广泛的问题。这份工作是一个完全合格、面向职业、具有旅行水平的职位。
~ 解决不同范围的问题，分析数据需要评估可识别因素。
~ 在选择获取解决方案的方法和技术时表现出良好的判断力。
~ 在自己的专业领域拥有高级内部和外部人员的网络。
~ 贡献许多成本中心的目标和目标：可能有助于服务线目标
~ 在收到诺华产品后24小时内报告与诺华产品相关的技术投诉/不良事件/特殊情况
~ 营销样本的分发（如适用）
Key Performance Indicators
~确保受控的文档系统、记录保留和信息服务，包括符合法规要求的电子记录保留流程。确保符合监管机构的要求。维护技术和非技术文档更改系统。 确保程序到位，以分类和维护记录。解释并执行所有文档格式、标准、策略和操作程序要求。可以识别提交组件，传达文档标准并协调监管档案的汇编。可以分析和评估数据，提取相关信息，准备信息摘要和所搜索材料的执行摘要。可以保持对产品信息的广泛了解，并与当地，区域和部门客户保持持续联系。
Work Experience
~运营管理和执行
~项目管理
~跨界协作
~职能广度
~跨文化经历
~管理危机
Skills
~生命科学
~法规遵从性
~文档管理
~项目管理
~数据分析
Language
英语
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
